ACARBOSE (Page 5 of 5)

Patients Receiving Sulfonylureas or Insulin:

Sulfonylurea agents or insulin may cause hypoglycemia. Acarbose Tablets given in combination with a sulfonylurea or insulin will cause a further lowering of blood glucose and may increase the potential for hypoglycemia. If hypoglycemia occurs, appropriate adjustments in the dosage of these agents should be made.

HOW SUPPLIED

Product: 71335-1583

NDC: 71335-1583-1 30 TABLET in a BOTTLE

NDC: 71335-1583-2 90 TABLET in a BOTTLE

NDC: 71335-1583-3 100 TABLET in a BOTTLE

Acarbose 50mg Tablet

Label Image
(click image for full-size original)
ACARBOSE
acarbose tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71335-1583(NDC:69543-121)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACARBOSE (ACARBOSE) ACARBOSE 50 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
SILICON DIOXIDE
Product Characteristics
Color WHITE (White to yellowish) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code cor;319
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71335-1583-1 30 TABLET in 1 BOTTLE None
2 NDC:71335-1583-2 90 TABLET in 1 BOTTLE None
3 NDC:71335-1583-3 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091343 02/01/2015
Labeler — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK (71335-1583), RELABEL (71335-1583)

Revised: 09/2020 Bryant Ranch Prepack

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